Head of QA Injectables Manufacturing
il y a 4 semaines
**Make your mark for patients**
We're on the lookout for a Head of QA Injectables Manufacturing to join our team in the Internal Manufacturing department, based in our office in Braine, Belgium.
About the Role
Together with appropriate management, responsible for the implementation and maintenance of an effective Quality Management System to assure that:
- Local technical operations related to the manufacturing of injectable pharmaceutical products (DP) complies with applicable national and/or international regulations and guidelines (GMP) & relevant company Quality Policies.
- Injectable pharmaceutical Products are manufactured and supplied in accordance with the company Quality Standards.
- To pro-actively help operations identify, develop, and implement quality and operational excellence improvements in response to business requirements, technical changes and regulatory requirement.
Who You'll Work With
You will report directly to the Head of Site QA Operations & Site QP, and you will collaborate closely with various stakeholders including Site QA staff, Braine Site Staff, the UCB injectables community, and Regulatory Affairs.
What You'll Do
Compliance and Quality Systems:
- Ensure that all Quality Assurance (QA) team operations align with relevant company quality systems and cGMP (current Good Manufacturing Practices).
- Ensure QA oversight of shop floor operations with company procedures and regulatory requirements.
- Facilitate timely and accurate batch approval or rejection according to regulations and established procedures.
- Provide necessary QA support to the Qualified Person (QP) for informed decisions.
- Internal Customer Relationships:
- Manage relationships with internal stakeholders, including the Head of Injectable Manufacturing.
- Ensure timely follow-up on product-related deviations, change controls, investigations, complaints, and release processes.
Team Leadership and Talent Development:
- Lead and develop the QA team, fostering talent recognition and growth.
- Be prepared to provide backup support to the team as needed.
- Actively contribute to simplifying and streamlining processes.
- Identify and remove roadblocks hindering quality improvement.
- Review and optimize procedures where necessary.
Inspections and Technical Expertise:
- Act as fronter during inspections by relevant health authorities.
- Provide answers to audit/inspection reports and develop relevant action plans.
- Offer technical expertise based on experience and share with injectable community.
- Interpret and provide direction to company management regarding Quality Assurance matters, regulatory CMC (Chemistry, Manufacturing, and Controls) files, and company policies.
Critical Issue Escalation and Solutions:
- Escalate critical quality issues to senior management promptly.
- Propose effective solutions to address challenges.
Interested? For this role, we're seeking the following qualifications, experience, and skills:
- Master's Degree
- Knowledge of worldwide regulations and best practice pertaining to GMP with special emphasis on injectable.
- Ability to plan and direct the actions of a group of professional Quality Assurance personnel.
- Demonstrate a fact-based decision-making process, accountability and delivering attitude.
- Ability to manage effectively and strategically plan to meet company objectives both short and long term.
- Excellent team player attitude and customer oriented.
- Fluent in English
Are you ready to ‘go beyond’ to create value and make your mark for patients? If this sounds like you, then we would love to hear from you
**About us**
UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 8,500 people in all four corners of the globe, inspired by patients and driven by science.
**Why work with us?**
At UCB, we don’t just complete tasks, we create value. We aren’t afraid to push forward, collaborate, and innovate to make our mark for patients. We have a caring, supportive culture where everyone feels included, respected, and has equitable opportunities to do their best work. We ‘go beyond’ to create value for our patients, and always with a human focus, whether that’s on our patients, our employees, or our planet. Working for us, you will discover a place where you can grow, and have the freedom to carve your own career path to achieve your full potential.
UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. We do not discriminate on the basis of race/color/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.
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